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Clinevo eTMF is a regulatory compliant, cloud based, user friendly, electronic trial master file in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.

Clinevo eTMF meets the regulatory compliance including

  • Digital content archiving
  • Security
  • Access control
  • Change controls
  • Audit trails and
  • System validation
Clinevo Technologies

Image Advanced Analytics

  • Gain powerful and actionable insights
  • Always know the status of all your documents
  • Instant notifications of expiring documents and missing signatures

Image Efficient Organization and Workflow

  • Inbuilt eTMF organization structure and configurable Organization structure for any Organization needs
  • Robust document lifecycle with Author, Review and eSign/Approval workflow.

Image Lower TCO and Easy Maintenance

  • Simplified technology stack – Build on Angular , JAVA and Oracle DB
  • More on Configurations and less customizations

Image Enhanced Security

  • Role based directory security
  • Controlled File Types
  • Password Protected file downloads

Image Faster User Adoption

  • Business team, CROs, Site personnel, external vendors and others can be trained on this system within few hours.

ImageExternal Systems Integration

  • Integrate with CDMS/ CTMS systems to get the study, Site, Patient and other information and dynamically create directory structure.

ImageSharing and Collaboration

  • Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method

Image Extendable Document Management System

  • System can be used as a focused eTMF or as general document management system for the entire organization

Image Anytime, Anywhere & Any device

  • User friendly web application can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device enables real-time site collaboration and document exchange

Image Regulatory Inspection Ready

  • Audit trail maintained for every operation
  • Fully compliant eSignatures for all stakeholdersabase locks
  • Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

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